Protective Effects of Long-term Remote Limb Ischemic Preconditioning For Carotid Artery Stenting


Phase 2 Results

Eligibility Criteria

Inclusion Criteria

1. Symptomatic or asymptomatic carotid artery stenosis. In symptomatic patients the degree of stenosis should more than 60% (Based on NASCET Criteria), in asymptomatic patients the degree of stenosis should more than 70% (Based on NASCET Criteria);
2. Tolerance to any of the study medications, including clopidogrel, aspirin and statins;
3. Can cooperate with and complete brain MRI examination;
4. Has a negative pregnancy test within 7 days before randomization and no childbearing potential;
5. Vascular ultrasound excluded intravascular thrombosis and unstable plaques in blood vessels of the bilateral upper limbs;
6. No hemorrhagic tendency;
7. Stable vital sign, normal renal and hepatic functions;
8. Informed consent.

Exclusion Criteria

1. Evolving stroke;
2. Prior major ipsilateral stroke, if likely to confound study endpoints;
3. Severe dementia;
4. Hemorrhagic conversion of an ischemic stroke within the past 60 days;
5. Chronic atrial fibrillation;
6. Myocardial infarction within previous 30 days;
7. Inability to understand and cooperate with study procedures or provide informed consent;
8. Participating in other device or drug trial that has not completed the required protocol follow-up period;
9. Any conditions that hampers proper angiographic assessment or makes percutaneous arterial access unsafe;
10. High risk candidates defined as the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST);
11. Any vascular, extremity soft tissue or orthopedic injury that may contraindicate bilateral arm ischemic preconditioning (e.g. superficial wounds and fractures of the arm);
12. Blood pressure cannot be controlled lower than 200 mmHg by medications;
13. Peripheral blood vessel disease (especially subclavian arterial and upper limb artery stenosis or occlusion).